BEUDAMED
    FDA Recall Open, Classified

    Cascade IOMAX Cortical Module, REF: 190296-200

    Recall: Z-2349-2024 · Initiated May 17, 2024

    Recall

    Recall Number
    Z-2349-2024
    Event Number
    94764
    Firm
    Cadwell Industries Inc
    FEI Number
    3020018
    Product Code
    GWF
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    May 17, 2024
    Posted
    July 12, 2024
    Address
    909 N Kellogg St, Kennewick, WA, 99336-7669

    Description

    Cascade IOMAX Cortical Module, REF: 190296-200

    Reason

    Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.

    Action

    On 5/17/2024, Cadwell Industries, Inc. issued "Urgent: Medical Device Recall" notification to affected consignees via E-Mail. Cadwell ask consignees to take the following actions: 1. Cease use of the device immediately and return all identified devices to Cadwell Industries, Inc. 2. Please complete the attached response form and return via email to [email protected]. 3. Please circulate this notice to all those who require awareness within your organization or to any organization whom you may have transferred the IOMAX Cortical Module to. 4. Please complete acknowledgement and product replacement form.

    Distribution

    US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom

    Quantity

    26 units